Obesity
Conditions
Brief summary
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of THDBH120 injection in participants with obesity. This study includes three multiple-ascending dose cohorts.
Interventions
Participants received THDBH120 by subcutaneous injection.
Participants received placebo by subcutaneous injection.
Sponsors
Tonghua Dongbao Pharmaceutical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 65 years (inclusive), male or female; * Body mass index (BMI) ≥ 28 kg/m²; * Diet and exercise control for at least 3 months before screening visit, and less than 5% self-reported change within the last 3 months.
Exclusion criteria
* Type 1 diabetes, type 2 diabetes, gestational diabetes, or other types of diabetes; * History of obesity attributable to endocrine diseases, monogenic mutations, or drug-induced causes, such as hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism; or weight gain resulting from increased non-fat mass (e.g., edema); * Presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg; * Prolonged QTcF interval on 12-lead ECG at screening (QTcF≥450 ms for males, \>470 ms for females), PR interval \>200 ms, or the presence of long QT syndrome, second- or third-degree atrioventricular block, left or right bundle branch block, Wolff-Parkinson-White syndrome, or any other clinically significant arrhythmias (except sinus arrhythmia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s) | 78 days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120. | Day 1 Pre-dose through Day 43 |
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120 | Day 1 Pre-dose through Day 43 |
| Change From Baseline in Body Weight | 43 days |
| Number of Participants With Anti-THBHD120 Antibodies | 78 days |
Countries
China
Outcome results
None listed